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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Twenty Veterans Affairs Medical Centers (VAMCs) were selected to participate in this cooperative study. The recruitment period was from 12/01/00 to 05/31/03.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A patient had to meet all the screening criteria for eligibility and had to sign a consent form with blood samples and meet all entry criteria for pre-randomization testing. Once the patient was deemed appropriate for the study, Hines completed the randomization assignment.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Our study had several limitations. Since we were studying veterans, the patients were predominantly men, and extrapolation of our findings to women must be done with caution.Changes in therapeutic agents have occurred since the design of our protocol